Tablet-based Interactive Distraction Preoperative Anxiety in Children: A Randomized Controlled Trial (TABLET)

September 2, 2018 updated by: Nathalie Lopez, Universidad de Valparaiso

Tablet-based Interactive Distraction for the Management of Preoperative Anxiety in Children: A Randomized Controlled Trial

Children develop anxiety during the induction of anaesthesia and video-games might reduce or alleviate it. The investigators intend to conduct a clinical trial to study the effect of tablet-based interctive games on alleviating preoperative anxiety.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It is estimated that 50% of children may suffer preoperative anxiety. They have a higher risk of generating postanesthetic delirium and behavioral changes in the postoperative period up to 67% of cases.

For the management of preoperative anxiety there are pharmacological and non-pharmacological treatments. Within the first group there's the use of benzodiazepines of short half life like midazolam, however, the use of this medication is not exempt of risks such as paradox reactions, respiratory depression, among others. This is why the non pharmacological mesures have taken force and every day there is more evidence regarding its effectiveness.

There are no reports in Chile or latin america regarding the use of this tools, this is why the investigators designed this study to prove the effectiveness of audiovisual distraction measures in reducing preparatory anxiety compared to premeditation with midazolam.

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Children aged 2-10 years, under major surgery ambulatory program at Hospital Carlos Van Buren, with no contraindication for the use of midazolam.

Exclusion Criteria:

Patients with cognitive impairment or sensory deficit Patients with previous history of major surgery will also be excluded Patients with myastenia "Hard airway" History of paroxystic reaction to benzodiazepines Attentional deficit hyperactivity disorder Sleep aphnea Full stomach Adenotonsillar hypertrophy Respiratory acute infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TIBD Tablet-based video distraction
Children will receive of tablet-based interctive games in preoperatory room
Device: TIBD
Table-based Interactive Distraction using video-games will be used to prove efficacy in preventing preoperative anxiety.
Active Comparator: Midazolam
Children will be premedicated with usual treatmente (midazolam)
Drug: Midazolam
Administration of midazolam oral or rectal 30 minutes to one hour prior to transfer to the theater.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short version of the modified Yale Preoperative Anxiety Scale(mYPAS-SF)
Time Frame: 6 hours

Difference between the measurement of the mYPAS-SF applied in the preoperative time and prior to induction.

The scale has 18 items in 4 categories. Maximum score is 100 points. The higher the score, the greater the anxiety.
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cooperation with the induction
Time Frame: 30 minuts

Scale with 10 items, 1 point for each one. 0 points shows an induction with perfect cooperation.

This scale will be applied at the moment of the induction by the anesthesiologist
30 minuts
Changes in postoperative behavior
Time Frame: 10 days
The Post Behavioral Behavior Change Questionnaire (PHBQ) will be applied at the postoperative surgical control (7-10 days after the intervention). This survey will be applied by people trained by the hospital's pediatric psychiatry team The higher the score, the more behavioral changes in the postoperative period
10 days
Emergence delirium
Time Frame: 1 hour
In the post-anesthesia recovery unit, the Emergency Delirium Scale for Pediatric Anesthesia (PAED) will be applied every 15 minutes during the first 30 minutes of their stay in the unit. Score goes from 0 to 20. Scores greater than 10 is considered as delirium.
1 hour
Parents Satisfaction
Time Frame: 10 minuts
A gradual scale will be applied to the parents of the patient upon discharge from hospital.
10 minuts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Valparaiso

Collaborators

Hospital Carlos Van Buren

Investigators

  • Study Director: Nathalie López, MD, Universidad de Valparaíso Chile
  • Principal Investigator: Anamaria Correa, MD, Universidad de Valparaíso Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2018

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

July 30, 2020

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (Actual)

May 21, 2018

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 2, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UV-1-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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